Compounded Versions of Wegovy, Ozempic Under Legal Scrutiny
Medically reviewed by Drugs.com.
By Physician’s Briefing Staff HealthDay Reporter
WEDNESDAY, June 21, 2023 -- The maker of three popular drugs that treat weight loss and diabetes said Tuesday that it has begun legal proceedings against businesses that are selling compounded versions of its products that are not approved by the U.S. Food and Drug Administration.
In a statement, the company said it is telling these med spas, weight loss clinics, and compounding pharmacies "to cease and desist from false advertising, trademark infringement, and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide."
Novo Nordisk makes the weight loss drug Wegovy and the diabetes drugs Ozempic and Rybelsus, and semaglutide is the key ingredient in those medications.
"These unlawful marketing and sales practices … have created a high risk of consumer confusion and deception as well as potential safety concerns," Novo Nordisk said. "Compounded products do not have the same safety, quality, and effectiveness assurances as our FDA-approved drugs and may expose patients to health risks. Novo Nordisk cannot validate the safety or effectiveness of products claiming to contain semaglutide that are not one of our own branded products. Novo Nordisk is the only company in the U.S. with FDA-approved products containing semaglutide, and no FDA-approved generic versions of semaglutide currently exist."
In May, the FDA also warned customers about these alternate products and the compounding of these medications, noting that people have reported adverse events and that patients "should not use a compounded drug if an approved drug is available."
But two of the Novo Nordisk drugs, Ozempic and Wegovy, have been in short supply since last year. "When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic Act," the FDA said in its warning, but the drugs are not reviewed for quality or safety. The compounded versions of semaglutide may be using salt forms, such as semaglutide sodium and semaglutide acetate, with different active ingredients than those approved by the FDA.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted June 2023
Read this next
One in Five Children Globally Has Excess Weight
TUESDAY, June 11, 2024 -- One in five children or adolescents globally experience excess weight, according to a study published online June 10 in JAMA Pediatrics. Xinyue...
Insulin-Treated T2D Patients Unwilling to Participate in Intensive Lifestyle Intervention
MONDAY, June 10, 2024 -- For adults with advanced, insulin-treated type 2 diabetes (T2D), willingness to participate in an intensive lifestyle intervention (ILI) is very low...
Greater Reduction Seen in Mortality With Bariatric Surgery Than GLP-1 RAs
MONDAY, June 10, 2024 -- Bariatric metabolic surgery (BMS) is associated with a greater reduction in mortality than glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.